Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial

The EATERS Trial

The aim of this study is to investigate the effect of early, supplementary parenteral nutrition following emergency laparotomy. Currently, parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible. However, little data exists on the optimal timing of parenteral nutrition. Oral and enteral nutrition is encouraged. Participants will randomized on the second postoperative day if their calorie intake (oral + enteral) is below 30% of the calculated requirement. Patients will be randomized to early (postoperative day 2) or postponed (postoperative day 5) start of parenteral nutrition. The combined oral + enteral + parenteral calorie target is 70-80% of the calculated requirement. Participants in the postponed group will be re-assessed on postoperative day 5, and if their calorie intake is less than 50% parenteral nutrition will be administered. The intervention will continue until oral + enteral intake is at least 70% of the calculated requirement or the participant is at his/her habitual intake.

2023-10-18

2025-10-25

2026-01-01

Recruiting

Early phase I

342

Inclusion Criteria: * Age \> 18 * Emergency primary midline laparotomy * Preoperative NRS-2002 (nutritional risk screening) score \< 7 * No contraindications for oral or enteral nutrition after surgery * Unable to tolerate or take in at least 30% of calculated calorie requirement on postoperative day 2 * Capable of providing informed consent at the time of inclusion Exclusion Criteria: * Laparotomy without closure of the abdominal aponeurosis * Non-midline incision * Laparoscopic procedure * Limiting mental or psychiatric disorders rendering participation unethical or unrealistic * Patients with a very limited expected remaining time of living (\< 3 months) * Preoperative NRS-2002 = 7 * Pregnant or breastfeeding women * Refusal to participate * Emergency reoperations

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized study with two study groups', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 342, 'type': 'ESTIMATED'}}

2024-02-06